In a recent Q&A session with the FDA, they shared valuable insights into the progress of the dual eSTAR submission pilot program with Health Canada. This pilot program aims to assess the feasibility of using a single eSTAR application for medical device approvals in both the US and Canadian markets. Nine medtech manufacturers were selected earlier this year to participate in the pilot, and the results thus far have been encouraging. Of the nine participants, five have received clearance for their submissions, with the remaining four still in progress. This early success demonstrates the potential of the dual eSTAR approach to streamline the regulatory process and expedite approvals.
During the initial stages of the pilot program, the FDA identified some confusion among participants regarding the submission process for a single eSTAR application in both Canada and the US. To address this, the agency emphasized the importance of companies reusing “region agnostic” documents and attachments, such as device descriptions and EMC 60601-1-2 test reports. Region-specific information, such as cover letters, pre-submission correspondence, and fees, should be separated and submitted accordingly. However, as things stand, this means that manufacturers need to maintain separate eSTAR documents for US and Canadian markets.
To further streamline the process, the pilot program now incorporates a feature that automatically deletes region-dependent attachments when a user selects the country for submission. In the future, this enhancement may ensure that only relevant documents are submitted to the respective regulatory bodies, reducing the risk of errors and delays.
The dual eSTAR submission pilot program holds promise for simplifying and expediting medical device approvals in both the US and Canada. As the pilot progresses, we can expect further refinements and enhancements to the process, which could lead to a more efficient and harmonized regulatory landscape for medtech manufacturers.To learn more about how your organization can prepare for eSTAR, watch this joint webinar with FDA eSTAR creator, Patrick Axtell.
Additional Resources:
FDA: Health Canada and FDA eSTAR Pilot Page
Health Canada: Health Canada eSTAR Pilot